Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must have completed study CN012-0026, CN012-0027 or CN012-0056. * Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study. * Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed. * At entry into this study, or any time during the…
Interventions
- DrugKarXT
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
Locations (416)
- Local Institution - 1029Homewood, Alabama
- Local Institution - 1-13H98LK9Chandler, Arizona
- Local Institution - 1227Chandler, Arizona
- Local Institution - 1116Chandler, Arizona
- Local Institution - 1247Gilbert, Arizona
- Local Institution - 1217Phoenix, Arizona